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OpenTrials
Completed

NCT Number: NCT03029078

FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?

Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug Resistant (XDR) bacteria by performing a fecal transplantation.

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Key information

Conditions

Microbial Colonization Bacterial Peritonitis Communicable Diseases Disease Attributes Faeces Smearing Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Raymond Poincaré

Garches, 92380, France

About this study

Main objective:

Evaluate the eradication of the colonization of patient harboring XDR bacteria after a fecal transplantation from a healthy donor.

Secondary objectives:

English Evaluate the side effects of this procedure and tolerability. Evaluate the efficacy of the transplant if the patient is harboring glycopeptid resistant enteroccus (GRE) or carbapenem resistant enterobacteriae (CRE)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient harboring a VRE or CRE bacteria
  • Colonization confirmed by our microbiology department, including at least 3 positives swabs in the last month

Exclusion criteria

  • Pregnant woman or breastfeeding
  • immunosuppression including AIDS, corticosteroids over 60mg/day
  • ongoing antibiotic treatment at the day of inclusion
  • impossibility to obtain a signed consent form.

Treatment and study plan

Fecal Microbiota Transplant

Drug

We will perform a fecal microbiota transplant for patients harboring XDR bacteria in their digestive tract

Other names: FEDEX

Primary outcomes

  1. Negativation of digestive tract colonization

    Time frame: At one week, 2 weeks, one month up to 6 months

    Negativation of the rectal swab performed, free from CRE or GRE

Secondary outcomes

  1. Metagenomics profile between donor and recipient depending on decolonization

    Time frame: At one week, 2 weeks, one month up to 3 months

    Study with a universal super donor in order to improve efficacy

Sponsors and collaborators

Lead sponsor

Centre d'Investigation Clinique et Technologique 805

Other

Registry information

Acronym: FEDEX

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jan 24, 2017
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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